Biocides (Amendment No. 3) Regulations, 2013

L.N. 347 of 2013

PESTICIDES CONTROL ACT

(CAP. 430)

Biocides (Amendment No. 3) Regulations, 2013

IN exercise of the powers conferred by articles 4 and 5 of the

Pesticides Control Act, the Minister for Sustainable Development, the

Environment and Climate Change, in consultation with the Minister

for Health, has made the following regulations:-

(1) The title of these regulations is the Biocides Citation, scope

(Amendment No. 3) Regulations, 2013, and these regulations shall be and

commencement.

read and construed as one with the Biocides Regulations, hereinafter S.L. 430.03

referred to as "the principal regulations".

(2) The scope of these regulations is to transpose Commission

Directive 2013/41/EU of 18 July 2013 amending Directive 98/8/EC

of the European Parliament and of the Council to include 1R-trans

phenothrin as an active substance in Annex I thereto.

(3) These regulations shall come into force as from 1st

September 2015.

Immediately after item 64 in Part A of Schedule I to the Amends

Schedule I to

principal regulations, there shall be added the following new item

the principal

regulations.

No

Common

IUPAC

Minimum

Date of

Deadline

Expiry

Prod

Specific provisions (*)

Name

Name

purity of

inclusion

for

date of

uct

Identifica

the active

complian

inclusion

type

-tion

substance

ce with

Numbers

in

the

Article

biocidal

16(3)

product

(except

as placed

for

on

the

products

market

containin

g more

than one

active

sub-

stance,

for which

the

deadline

to

comply

with

Article

16(3)

shall be

the one

set out in

the last

of

the

inclusion

decisions

relating

to

its

active

subs-

tances)

" 65

1R-trans

1R-trans

89% w/w

The Union level risk

pheno-

pheno-

of 1R-

Septem-

August

August

assessment did not address

thrin

thrin

trans

ber 2015

all potential uses and

IUPAC

pheno-

exposure scenarios. When

name: 3-

thrin

assessing the application

phenoxy-

for authorisation of a

benzyl(1

product in accordance

R,3R)-

with Article 5 and Annex

2,2-

VI, Member States shall

dimethyl-

assess, where relevant for

3-(2-

the particular product,

methyl-

those uses or exposure

prop-1-

scenarios and those risks

enyl)

to human populations and

cyclopro-

to environmental

panecar-

compartments that have

boxylate

not been representatively

EC No

addressed in the Union

247-431-

level risk assessment.

2 CAS

Member States shall

No

ensure that authorisations

26046-

are subject to the

85-5

following conditions

Sum of

95,5%

(1) safe operational

all

w/w for

procedures shall be

isomers

the sum

established for ultra low

IUPAC

of all

volume (ULV)

name: (3-

isomers

application, and products

Phenoxy-

shall be used with

phenyl)

appropriate personal

methyl

protective equipment,

2,2-

unless it can be

dimethyl-

demonstrated in the

3-(2-

application for product

methyl-

authorisation that risks can

prop-1-

be reduced to an

enyl)

acceptable level by other

cyclopro-

means;

pane-1-

(2) for products containing

carboxy-

1R-trans phenothrin that

late EC

may lead to residues in

No: 247-

food or feed, Member

404-5

States shall verify the need

CAS No

to set new or to amend

26002-

existing maximum residue

80-2

levels (MRLs) according

to Regulation (EC) No

470/2009 or Regulation

(EC) No 396/2005, and

take any appropriate risk

mitigation measures

ensuring that the

applicable MRLs are not

exceeded;

(3) where appropriate,

measures shall be taken to

protect honey bees.".

€0.36